NCT03343522

Brief Summary

Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator agents and blood vessels number. However, the investigators could not find previous works that studied the microvascular function in response to exercise training in HIV patients. Objectives: To study the impact of aerobic exercise training in endothelial function of HIV patients. In addition, the investigators will verify the association of the physical fitness to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients. Methods: The study subjects will be composed by HIV patients, that will be randomly divided in two different groups: exercised and sedentary. The subjects will be tested before and after training in regards to endothelial function, nitric oxide bioavailability, physical fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary exercise test, and biochemical tests; respectively. The exercise training will be performed in a treadmill for 12 weeks, 3 times a week, 40 minutes each section. Expected Results: The investigators expect to achieve markers that will help in understanding the interaction of HIV with several factors that contribute to an increased endothelial function after exercise training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

5.1 years

First QC Date

November 10, 2017

Last Update Submit

March 6, 2023

Conditions

HIV/AIDS

Keywords

Vascular functionPhysical trainingLaser Speckle Contrast Imaging

Outcome Measures

Primary Outcomes (1)

  • Skin microvascular blood flow

    Microvascular reactivity will be evaluated by laser speckle contrast imaging with laser wavelength of 785 nm in combination with iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP) for noninvasive and continuous measurements of cutaneous microvascular flow changes in the forearm.

    Baseline and 3 months

Secondary Outcomes (5)

  • Peak Oxygen consumption

    Baseline and 3 months

  • Nitrite/nitrate

    Baseline and 3 months

  • Body fat

    Baseline and 3 months

  • Forearm macrovascular blood flow

    Baseline and 3 months

  • Capillary density

    Baseline and 3 months

Study Arms (2)

Sedentarism

NO INTERVENTION

Patients assigned to this arm shall not perform regular exercise training.

Exercise Training

EXPERIMENTAL

Patients assigned to this arm will be enrolled in exercise training program.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).

Exercise Training

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • sedentarism for at least 6 months;
  • diagnosis of HIV infection.

You may not qualify if:

  • opportunistic diseases;
  • nephropathies;
  • cardiovascular diseases;
  • locomotor limitations;
  • liver diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rio de Janeiro State University

Rio de Janeiro, Rio de Janeiro, 20550-900, Brazil

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Juliana P Borges, PhD

    Insituto Nacional de Cardiologia and Rio de Janeiro State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 17, 2017

Study Start

November 10, 2017

Primary Completion

December 20, 2022

Study Completion

March 3, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)